multiple myeloma multiple myeloma
Conditions
Interventions
DRd(cycle/4 weeks)/DVd(cycle/3 weeks) including daratumumab administration(16.0 mg/Kg) every 1-3 weeks, until disease progression or unmanageable toxicity
Sponsors
Inokuchi Koiti
Nakamura Tetsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Relapse/refractory multiple myeloma currently with extramedullary disease 2) Extramedullary disease, defined as plasmacytoma outside bone marrow, has a single diameter of 2 cm or more than 2 cm and at least one measurable disease as follows serum M-protein 0.5g/dL or or more than 0.5g/dL urine M-protein 200 mg/24h or more than 200 mg/24h serum free light chain (involved light chain) 100 mg/L or more than 100 mg/L 3) Normal organ function absolute neutrophil count 1000/mm3 or more than 1000/mm3 platelet count 50,000/mm3 or more than 50,000/mm3 hemoglobin 8.0 g/dL or more than 8.0 g/dL calculated creatinine clearance (using Cockcroft-Gault equation) 30 mL/min or more than 30 mL/min or Cr 3.0mg/dL or less than 3.0mg/dL total bilirubin upper limit x 2 or or less than upper limit x 2 ALT, AST upper limit x 3 or or less than upper limit x 3 4) Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (including PS3 according bone diseases) 5) Patients who can comply the proper procedure of RevMate 6) Provide informed written consent 7) Willing to provide bone marrow and extramedullary samples for correlative research purposes
Exclusion criteria
Exclusion criteria: 1)pregnant or breastfeeding females 2)patients with other active neoplasm 3)patients who were previously treated with daratumumab 4)known active systemic infection 5)known hepatitis B surface antigen-positive status 6)known hepatitis C antibody-positive status 7)known human immunodeficiency virus (HIV) antibody-positive status 8)patients undergoing major surgery (except surgery for myeloma bone disease) within 14 days prior to the registration 9)patients undergoing radiation therapy within 7 days prior to the registration 10)evidence of current uncontrolled cardiovascular conditions including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months 11)any serious medical or psychiatric illness that could, in the investigator's opinion,potentially interfere with the completion of treatment according to this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| extramedullary plasmacytoma response | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate of multiple myeloma biochemical response incidence of adverse events progression-free survival overall survival | — |
Contacts
Public ContactHideto Tamura
Department of Hematology, Nippon Medical School Hospital
Outcome results
None listed